非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号FN-706-231101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.263881553876903879223877813850363873170.34
211.193832543821063826800.22
单位质量响应值RSD%判断
34397.6034198.390.42数据可信
供试品溶液-24091001-1批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min189025-8902523.36116.5451.3223.3616.5451.32
2104158-10415827.33227.33
361655-6165516.17916.18
471157-7115718.67218.67
531385-313858.2368.24
620703-207035.4335.43
10min1193226-19322650.70442.8622.8850.7442.8822.90
2192433-19243350.49650.54
3163180-16318042.82042.85
4195834-19583451.38851.42
5119471-11947131.35031.36
6115783-11578330.38230.39
15min1243514-24351463.90058.579.6964.0258.669.72
2235172-23517261.71161.84
3217737-21773757.13657.23
4245090-24509064.31464.43
5192325-19232550.46850.53
6205341-20534153.88353.94
20min1271519-27151971.24966.846.3471.4867.046.37
2261153-26115368.52968.76
3253250-25325066.45566.65
4269388-26938870.69070.91
5229512-22951260.22660.38
6243514-24351463.90064.05
30min1310988-31098881.60675.525.0781.9575.825.10
2290647-29064776.26876.61
3282380-28238074.09974.40
4294933-29493377.39377.73
5268793-26879370.53370.78
6279054-27905473.22673.48
45min1330915-33091586.83581.143.9287.3281.573.95
2309386-30938681.18581.66
3303321-30332179.59480.02
4310907-31090781.58582.06
5294562-29456277.29577.66
6306141-30614180.33480.71
60min1340402-34040289.32484.003.5589.9584.573.57
2320440-32044084.08684.70
3312446-31244681.98882.55
4320154-32015484.01184.62
5306933-30693380.54281.04
6320234-32023484.03284.54
极限1360035-36003594.47686.794.4295.2587.504.43
2325061-32506185.29986.05
3323073-32307384.77785.47
4327618-32761885.97086.72
5320655-32065584.14384.77
6328031-32803186.07886.73
非奈利酮片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号FN-706-231101对照品来源自制对照品使用方法直接使用
对照品含量(%)100.0对照品水分(%)0对照品稀释倍数1000
标示量(mg)10供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
111.263823613822643821713825863822303823220.05
211.193809933803383806660.13
单位质量响应值RSD%判断
33954.0034018.410.14数据可信
供试品溶液-24091001-2批-pH4.5
时间
(分钟)		样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)		平均(%)RSD%
5min142295-4229511.2005.5859.9511.205.5859.95
225767-257676.8236.82
319474-194745.1575.16
422066-220665.8435.84
58823-88232.3362.34
67982-79822.1142.11
10min1111046-11104629.40618.6644.2329.4318.6744.24
292106-9210624.39124.40
374297-7429719.67519.68
477566-7756620.54120.55
533291-332918.8168.82
634490-344909.1339.14
15min1164584-16458443.58434.7929.2243.6534.8329.23
2170357-17035745.11345.16
3141520-14152037.47637.52
4143349-14334937.96138.00
578920-7892020.89920.92
689572-8957223.72023.74
20min1210642-21064255.78152.5913.8055.9252.6913.84
2233972-23397261.95962.09
3211589-21158956.03256.14
4202565-20256553.64253.75
5159535-15953542.24742.30
6173183-17318345.86145.92
30min1263826-26382669.86568.137.4670.1068.327.50
2279637-27963774.05274.28
3271744-27174471.96272.16
4256761-25676167.99468.19
5226574-22657460.00060.12
6245194-24519464.93165.07
45min1303688-30368880.42177.375.5880.7777.665.62
2308212-30821281.61981.97
3301555-30155579.85680.17
4289144-28914476.56976.88
5263771-26377169.85070.07
6286568-28656875.88776.13
60min1322108-32210885.29981.674.8685.7882.104.91
2320420-32042084.85285.34
3315834-31583483.63784.09
4305747-30574780.96681.40
5281662-28166274.58874.93
6304757-30475780.70481.07
极限1330900-33090087.62785.352.2588.2585.922.30
2326267-32626786.40087.03
3326082-32608286.35186.94
4321008-32100885.00785.58
5310153-31015382.13382.60
6319491-31949184.60685.11
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